|Publication number||US6852099 B2|
|Application number||US 10/163,201|
|Publication date||Feb 8, 2005|
|Filing date||Jun 4, 2002|
|Priority date||Jun 4, 2002|
|Also published as||CA2487671A1, CA2487671C, DE60319377D1, DE60319377T2, EP1517640A1, EP1517640B1, US20030225380, WO2003101309A1|
|Publication number||10163201, 163201, US 6852099 B2, US 6852099B2, US-B2-6852099, US6852099 B2, US6852099B2|
|Inventors||Heinz Redl, Zafar Khakpour|
|Original Assignee||Baxter International Inc., Baxter Healthcare S.A.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (23), Referenced by (32), Classifications (11), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The invention relates to a device for applying liquids to body surfaces or body cavities. In one embodiment, the invention relates specifically to the application of tissue adhesive components with the assistance of a pressurized gas and a system for controllably applying the tissue adhesive components.
Devices for applying liquids to body surfaces are known. Devices which apply tissue adhesives using a medicinal gas are disclosed, for example, in EP 146 098 A and its corresponding U.S. Pat. No. 4,631,055 as well as EP 669 100 A and its corresponding U.S. Pat. No. 5,665,067, which are incorporated by reference as if fully set forth herein. A common tissue adhesive is fibrin, which usually comprises a fibrinogen solution, on the one hand, and a thrombin solution, on the other hand, which may be delivered by atomization to the site of application and applied thereto. This spray application may be used for external wound sealing, for example, to stop bleeding from a wound, or to assist in treating burns or skin grafts, and is particularly well suited for sealing wounds within body cavities. For this purpose, a multi-lumen tube or spray catheter may be introduced into the respective body cavity, e.g. by way of minimally invasive surgery, and advanced to a position proximate to the application site. Once positioned, the tissue adhesive may be applied to the application site.
One shortcoming associated with the aforementioned procedure arises when applying the tissue adhesive within a closed body cavity. When applying the tissue adhesive, excessive pressure may be built up within the closed body cavity. Similarly, the open distal end of the catheter may directly contact the inner tissue or organ during use. Both of these problems may result in health-damaging consequences to the patient. It is possible to provide the catheter with optical means, such as a fiber-optic light guide and lenses, and to connect a visualizing device thereto so that the movement of the catheter in the body cavity may be visually checked from the outside. However, this solution is overly complex for many cases and fails to adequately address the safety issues relating to the possible pressure build-up within the closed body cavity or the catheter contacting the tissue.
Therefore, it is an object of the present invention to provide a device and system which avoids the negative consequences of the development of high pressure in the body cavity or of the catheter's contact with body tissue during operation. In particular, the present invention provides safety precautions in the event of a pressure build-up or of the catheter contacting tissue during operation of the device. In addition, the present invention is capable of monitoring pressure within the closed cavity by introducing a flow and/or volume of the pressurized medicinal gas for monitoring the catheter tip and prevent contact with the tissue.
The present invention relates generally to the application of fluids to a body surface or cavity. These fluids can include tissue adhesives, hemostats, sealants, anti-adhesives, or any other fluid capable of being applied to a body surface or cavity. Much of the following description will address an embodiment wherein a device is used to controllably apply components of a tissue adhesive. It is to be understood, however that the device described can be used to deliver other fluids as stated above.
In one embodiment of the invention, a device for applying the components of a tissue adhesive comprises a multi-lumen tube or catheter. When referring to the tube or catheter the term “distal” will be used to refer to the tip of catheter which is inserted into a patient and the term “proximal” will be used to refer to the end of the catheter which is designed to be outside the body of the patient. The catheter of the present invention has lumens which terminate at the free distal end of the tube, a component delivery device to which the respective lumens of the tube are connected, a source of pressurized gas for supplying a medicinal gas under pressure thereto, a medicinal lumen within the multi-lumen tube and in communication with the pressure gas source, and a sensor capable of providing a sensor signal corresponding to an injection parameter. The sensor may include, without limitation, a contact sensor, a flow sensor, a volume sensor, or a pressure sensor. In particular, the sensor may provide information corresponding to an injection parameter, such as direct or indirect information relating to the pressure in the region of the distal end of the catheter. A switch device is provided for the pressurized gas supply. The switch device is controlled by a control system and may switch off the pressurized gas supply when the sensor signal corresponds to a predetermined limit value. In one embodiment, the pressure at the distal end of the tube or catheter is monitored by a pressure sensor, wherein a first reference value is determined depending on the conditions given, such as, for example, the gas pressure, ambient pressure, or the pressure in the body cavity etc. This first reference value is considered when setting the alarm level. When the alarm level is reached, as detected by the pressure sensor, the gas supply and, thus, the spray application is switched off.
The present invention may include a multi-lumen tube or catheter, which contains at least four lumens therein and which may include a transfer conduit member, positioned near the distal end, to which the pressurized gas source may be connected. The invention may include an adjacent measurement lumen, where the transfer conduit member includes an open annular passage between its outer periphery and an interior wall of the measurement lumen. The measurement lumen freely opens in the direction of the distal end of the multi-lumen tube, whereas the lumen to which the pressurized gas source is connected is sealingly closed around the transfer conduit member. This allows for monitoring of the pressure at a protected site within the catheter tube. Alternate monitoring systems include, without limitation, contact sensors, such as capacitive sensors, conductivity sensors, light sensors or ultrasonic sensors, which are directly attached to the tip of the catheter tube or to the front side of the distal end, thereby enabling the present invention to directly sense tissue contact.
In other embodiments, the pressure monitoring, which may be accomplished directly or indirectly, may be accomplished via a flow measurement or a volume measurement. Electrical lines would not necessarily be required in the catheter tube. An electromechanical pressure transducer may be attached or connected at the rear or proximal end of the catheter tube. The embodiment utilizing an electromechanical pressure transducer includes the aforementioned measurement lumen within the catheter tube. Accordingly, the catheter tube may have four lumens, i.e. two component delivery lumens for separately conveying the two components of the tissue adhesive, a lumen for conveying the pressurized gas, and a measurement lumen. The measuring lumen can communicate with the aforementioned transfer conduit member, and the tube may be provided with a transition region from the pressurized gas lumen to the measurement lumen so that the pressurized gas lumen will be closed at the distal end. The measurement lumen, in its forward-most region, will thereby be an extension of the pressurized gas lumen.
The measurement lumen may have an associated pressure transducer at its proximal end. In an alternate embodiment which uses capacitive sensors or other sensor devices, the measurement lumen may include corresponding electric signal lines towards the proximal end. The proximal end of the catheter tube may be connected to the control system, which may include electronic comparators associated with the sensors. The electronic comparators compare the sensor signal with a stored reference value defining the limit value. The control system may, in particular, comprise an electronic circuit capable of defining this reference value, which may depend on marginal conditions, such as surrounding pressure, pressure within the body cavity, etc.
The controllable switch device for the pressurized gas supply may comprise a solenoid valve which has a control input connected to the control system. Furthermore, a separate switch capable of actuation during operation, for example, a foot switch, may be connected to the control system to initiate operation of the spray application device. However, the operation of the device will be interrupted and the solenoid valve will be closed if the control system and sensors detect that the monitored parameter, e.g. the pressure, reaches the defined limit value or reference value. The control system then actuates the switch device, in particular the solenoid valve, accordingly. In this instance, a display unit as well as an alarm unit which are connected to the control system may additionally be actuated so as to trigger an optical and/or acoustical alarm and to signal to the operating person that either tissue contact or excessive pressure has been detected.
The invention will hereinafter be described in detail by way of preferred illustrative embodiments and with reference to the drawings. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention.
At the other end of the holder 3, finger grips 8 are provided which may comprise U-shaped enlargements 9 and 10 in which the flange ends 11 and 12 of the syringe bodies 1 and 2 are received such that the syringe bodies 1 and 2 are fixed in the direction of their longitudinal axes 13.
Between the channels 4 and 5, a gap 14 is provided for a guide rod 15. A penetrating bore 16 may be formed in the holder 3 in the region of the finger grips 8. The guide rod 15 may be connected with a common actuating device 17 for thumb yokes 18 and 19 of the syringe pistons 20 and 21.
Two conical tips 25 and 26 of the syringe bodies 1 and 2 project into appropriately shaped recesses of a connecting head 27 and are connected therewith. Within the connecting head 27, separate conveying channels 28 and 29 lead respectively from each conical tip 25 and 26 to the front side of the connecting head 27. Moreover, a further conveying channel 30 is provided in the connecting head 27 for receiving a medicinal gas, which likewise leads to the front side of the connecting head 27 adjacent the conveying channels 28 and 29. Furthermore, as is illustrated in
The connecting head 27 may be connected to a four-lumen catheter tube 32. As shown in
By applying pressure either to the individual pistons 18 and 19, or to the actuating device 17, the components to be mixed are supplied to the site of application.
Depending on the choice of the speed and amount of the medicinal gas applied during the application, the components may be administered in liquid form or in an atomized form.
In addition to foot switch 37, a sensor 47 may be connected to the processor unit 43 which serves to check the correct connection of the catheter tube 32 in the connecting head 27, and the correct connection of the hose ducts 30 a and 31 a. Sensor 47 may be an optical sensor, a mechanical sensor, or an inductive sensor. (See the sequences illustrated in
In operation, solenoid valve 34 is opened by means of the foot switch 37 so as to effect a gas supply from the source 33 of pressurized gas to the gas conveying lumen 30′ in the catheter tube. However, if sensor 35 detects an inadmissible state during operation, the processor unit 43 causes a movement of the solenoid valve 34 to the off or closed position so that gas under pressure can no longer be provided to the catheter tube 32. For example, in one embodiment utilizing a pressure sensor, the pressure sensor may immediately sense an inadmissible pressure build-up in the region of tip 38 of the catheter tube 32, which is determined by comparing the sensor signal with the reference value in the comparator 44. The processor unit 43 may be designed so that if the inadmissible condition, e.g. an excessive pressure, persists for a short duration and them terminates, the processor unit 43 will automatically move the solenoid valve 34 into the open position again, so long as the foot switch 37 is still pressed down, so that the gas supply can be continued immediately. However, if the inadmissible condition continues for a longer period of time, the gas supply will remain blocked via the solenoid valve 34, so that the cause of the inadmissible condition may be determined and removed before the operation of the device can be continued. It may be provided that following a safety shut-off, as described above, switching on or opening the solenoid valve 34 is only possible after a “reset” input by the user, e.g. by actuating a key (not illustrated), is optionally made after a given time has passed.
The processor unit 43 of
If the readiness of the device has been checked in this manner and it has been assured that a new catheter tube 32 is being utilized, this catheter tube will also be calibrated when the device is put into operation. The corresponding calibration process is illustrated in the diagram of FIG. 13. After a first starting step, shown at block 70, the system checks, at a second step shown at block 71, whether the catheter tube 32 has been correctly connected. If the connection is not correct an alarm is delivered, as shown in block 72, and the device is switched off. If, however, the catheter tube 32 has been correctly connected, block 73 illustrates the subsequent step where the pressurized gas is shortly turned on and immediately turned off again. This is done automatically under the control of processor 43 or of the control and monitoring unit 40. The pressure pulse obtained is “sent” through the catheter tube 32, and subsequently, if the catheter tube 32 is all right, the relative pressure value will equal zero. At block 74, the relative pressure is measured and taken as a zero value. Subsequently, at block 75, the system checks to determine whether the actual zero value differs from the atmospheric pressure, i.e. from the pressure value previously calibrated as the zero value. If a difference is detected, block 76 illustrates an alarm signal that is delivered and the device is turned off. As was described with respect to block 72, block 76 relays to the beginning of the process. By repeatedly measuring the atmospheric pressure and repeatedly delivering pressure pulses as described, clogging of the catheter can be prevented and production errors can be detected.
If the actual zero value in step 75 equals the atmospheric “zero value”, block 77 illustrates the performance of a sealing check routine, wherein the solenoid valve 34 is turned on and off and pressure values are taken at pre-determined points of time (See FIG. 16).
Block 78 illustrates that if, during this sealing check routine, it is found that the connection of the catheter tube 32 is not tight, the alarm signal of block 79 is delivered, the device is turned off, and it is relayed to the beginning of the process. However, if at the check at block 78 it is found that the catheter tube 32 (including the connecting head 27) is sealingly connected, the solenoid valve 34 is then switched on, as shown at block 80, and, as shown at block 81, the optimum working point of the catheter is determined. In doing so, this optimum working point is obtained with a maximum distance to zero point (See point 103 of FIG. 15). At block 82 the alarm value which has already been adjusted is read in. At block 83 the system checks whether the optimum working point is higher, as an absolute value, than the adjusted alarm value. If the optimum working point is not higher then the adjusted alarm value, as shown at block 84, an alarm signal is delivered and the device is shut off and relayed to the beginning of the process. Otherwise, as shown at block 85, the solenoid valve 34 is turned off again and, as shown at block 86, the initialization of the catheter is registered as valid. At the end of the program process, as shown at block 87, the readiness of the device including the catheter is signaled.
If the checking step 98 yields the result that the actual pressure value has not reached the alarm limit value, as shown at block 100, an acoustic and/or optical signal for the proper functioning of the device is delivered. An acoustic signal is particularly viewed as suitable since it can be transmitted immediately to the clinician using the device with the information that the proper function is given (or, for example, that an error has been found), without the clinician having to take his eyes off the patient. The system may also provide for the frequency and/or the volume of the acoustic signal to be dependent on the actual, measured pressure value (e.g., the higher the pressure, the higher, or louder, respectively, the sound).
The cycle illustrated in
The system is designed such that after the solenoid valve 34 has been switched on the pressure sequence shown in
As discussed above, the distance D from the open end of the transfer conduit member 58 to the catheter end 38 is important for the negative pressure formation in the measurement lumen 31′. For example, distance D must not be too long or else the negative pressure to be measured will not be produced, as compared to the ambient pressure, and an overpressure will be formed. The maximum negative pressure (level 103) results when the pressurized gas is freely released into the environment (See FIG. 15).
The invention is not limited to the previously described example which, at present, is considered to be the preferred embodiment, but further changes and modifications are possible within the scope of the invention. For example, the present invention can be used to apply a variety of fluids to a body surface or cavity, including tissue adhesives, hemostats, sealants, or anti-adhesives. Furthermore, electronic sensors may be used in the region of the catheter tip 38, as illustrated by way of example in
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|U.S. Classification||604/289, 604/82|
|International Classification||A61M25/00, A61M35/00, A61B17/00, A61B17/12|
|Cooperative Classification||A61B2017/00022, A61B17/00491, A61B2017/00544, A61B2017/00495|
|Feb 12, 2003||AS||Assignment|
Owner name: BAXTER HEALTHCARE S.A., SWITZERLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:REDL, HEINZ;KHAKPOUR, ZAFAR;REEL/FRAME:013427/0916
Effective date: 20020821
Owner name: BAXTER INTERNATIONAL INC., ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:REDL, HEINZ;KHAKPOUR, ZAFAR;REEL/FRAME:013427/0916
Effective date: 20020821
|Aug 8, 2008||FPAY||Fee payment|
Year of fee payment: 4
|Aug 8, 2012||FPAY||Fee payment|
Year of fee payment: 8